Drive Mechanisms Suitable for Use in Drug Delivery Devices

ABSTRACT

The present invention relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, wherein a number of pre-set doses of medicinal product can be administered. In particular, the present invention relates to such drug delivery devices where a user may activate the drug delivery device.

THE TECHNICAL FIELD OF THE INVENTION

The present invention relates to drive mechanisms suitable for use indrug delivery devices, in particular pen-type injectors, wherein anumber of pre-set doses of medicinal product can be administered. Inparticular, the present invention relates to such drug delivery deviceswhere a user may activate the drug delivery device.

DESCRIPTION OF THE RELATED ART

Such drug delivery devices have application where persons without formalmedical training, i.e., patients, need to administer an accurate andpredefined dose of a medicinal product, such as heparin or insulin. Inparticular, such devices have application where medicinal product isadministered on an irregular basis over a short-term or long-termperiod.

These circumstances set a number of requirements for drug deliverydevices of this kind. The device must be robust in construction, yeteasy to use in terms of the manipulation of the parts, understanding bya user of its operation and the delivery of the required dose ofmedicament. Dose setting must be easy and unambiguous. Where the deviceis to be disposable rather than reusable, the device should be cheap tomanufacture and easy to dispose of (preferably being suitable forrecycling). To meet these requirements the number of parts required toassemble the device and the number of material types the device is madefrom need to be kept to a minimum.

User operated drug delivery devices are well known within the medicalfield.

WO 9626754 A2 teaches a mechanism for accurate dispensing of pre-setquantities of medicament from a syringe wherein a rotatable plunger hasa number of parallel racks on its internal surface each of which comesinto engagement with a first tooth wheel as the plunger rotates when adose is set. The device has a second tooth wheel that rotates with thefirst tooth wheel thus driving a thrust rod into the syringe when theselected dose is delivered. Whilst this device provides a usefulembodiment for administering a pre-set dose the intuitiveness of settinga dose remains unsolved as parts need to be rotated during dose setting.

An injection device is disclosed in WO 01/95959 A1 having a gearbox inwhich a dose is set by rotating a dose setting member and the gearbox,and by which an injection button elevates from an end of the syringe adistance proportional to the set dose and wherein the set dose can beinjected by pressing home the injection button to its not elevatedposition. Whilst this device provides a useful embodiment foradministering a pre-set dose once again the intuitiveness of selling adose remains unsolved as parts need to be rotated during dose setting.

U.S. Pat. No. 5,782,633 teaches an applicator for a dental compoundhaving an elongated implement body and a gearwheel/pinion pair connectedto two moving racks, one rack located on a pusher rod and another racklocated on a ram.

In WO 03/080160 A1 a medication dispensing apparatus having a gear setis disclosed wherein the gear set consists of a first pinion in meshedengagement with a rack of a plunger and a second pinion in meshedengagement with a rack of a drive member of the apparatus to provide theapparatus with a mechanical advantage. The first pinion and the secondpinion are both independent components having a unidirectional couplingset between.

Surprisingly it was found that the drive mechanism according to instantinvention without having two pinions provides a valuable technicalalternative for push-pull drive mechanisms, wherein reduced force isneeded to actuate the mechanism. This is achieved by the introduction ofa piston rod and rotating means as defined by instant invention. Furtherthe drive mechanism according to instant invention further provides theadvantage of intuitive and easy to use dose setting.

DESCRIPTION OF THE INVENTION

According to a first aspect of the present invention, a drive mechanismfor use in a drug delivery device is provided comprising:

a housing having a proximal and a distal end;

a drive member located within the said housing such that the said drivemember is movable longitudinally;

a piston rod adapted to operate through the housing and transfer a forcein the longitudinal direction to the distal end of the drug deliverydevice;

a rotating means releasably engaged with the said piston rod and engagedto the said drive member and engaged to the said housing;

characterized in that,

-   -   a) when the said drive member moves proximally with respect to        the said housing the said rotating means moves proximally with        respect to the said piston rod;    -   b) when the said drive member moves distally the said rotating        means moves distally displacing the said piston rod towards the        distal end of the device.

In a preferred embodiment of the drive mechanism of instant inventionthe said drive member is non-rotatable with respect to the said housing.

In another preferred embodiment of the drive mechanism of instantinvention the said piston rod is non-rotatable with respect to the saidhousing.

In a further preferred embodiment of the drive mechanism of instantinvention the rotating means is a gear.

In yet a further preferred embodiment of the drive mechanism of instantinvention the gear is free to translate relative to the said piston rod.

In another further preferred embodiment of the drive mechanism ofinstant invention the engagement between the piston rod and the gearacts through the axle of the said gear.

In yet another further preferred embodiment of the drive mechanism ofinstant invention the gear is designed to be engaged with a rack locatedon the drive member and a rack located on the housing.

In a further embodiment of the drive mechanism of instant invention therotating means is a lever.

In yet another embodiment of the drive mechanism of instant inventionthe rotating means is a pulley.

In yet a further embodiment of the drive mechanism of instant inventionthe rotating means is a lever assembly.

The term “drug delivery device” according to instant invention shallmean a single-dose or multi-dose or pre-set dose or pre-defined,disposable or re-useable device designed to dispense a user selectableor pre-defined dose of a medicinal product, preferably multiplepre-defined doses, e.g. insulin, growth hormones, low molecular weightheparins, and their analogues and/or derivatives etc. Said device may beof any shape, e.g. compact or pen-type. Dose delivery may be providedthrough a mechanical (optionally manual) or electrical drive mechanismor stored energy drive mechanism, such as a spring, etc. Dose selectionmay be provided through a manual mechanism or electronic mechanism.Additionally, said device may contain components designed to monitorphysiological properties such as blood glucose levels, etc. Furthermore,the said device may comprise a needle or may be needle-free. Inparticular, the term “drug delivery device” shall mean a disposableneedle-based pen-type device providing multiple pre-defined doses havingmechanical and manual dose delivery and dose selection mechanisms, whichis designed for use by persons without formal medical training such aspatients. Preferably, the drug delivery device is of the injector-type.

The term “housing” according to instant invention shall preferably meanany exterior housing (“main housing”, “body”, “shell”) or interiorhousing (“insert”, “inner body”) having a unidirectional axial couplingto prevent proximal movement of specific components. The housing may bedesigned to enable the safe, correct, and comfortable handling of thedrug delivery device or any of its mechanism. Usually, it is designed tohouse, fix, protect, guide, and/or engage with any of the innercomponents of the drug delivery device (e.g., the drive mechanism,cartridge, plunger, piston rod) by limiting the exposure tocontaminants, such as liquid, dust, dirt etc. In general, the housingmay be unitary or a multipart component of tubular or non-tubular shape.Usually, the exterior housing serves to house a cartridge from which anumber of doses of a medicinal product may by dispensed.

In a more specific embodiment of instant invention, the exterior housingis provided with a plurality of maximum dose stops adapted to be abuttedby an axial stop provided on the drive member.

The term “engaged” according to instant invention shall particularlymean the interlocking of two or more components of the drivemechanism/drug delivery device, e.g. a spline, thread, or meshed teethconnection, preferably the interlocking of meshed teeth of components.

The term “drive member” according to instant invention shall mean anycomponent adapted to operate through/within the housing, designed totranslate axial movement through/within the drug delivery device,preferably from an actuation means to the piston rod. In a preferredembodiment the drive member is further releasably engaged with thepiston rod. The drive member may be of unitary or multipartconstruction.

The term “releasably engaged” according to instant invention shallpreferably mean that two components of instant mechanism or device arejoined for translation of force or movement in one direction only,preferably during dispense.

The term “piston rod” according to instant invention shall mean acomponent adapted to operate through/within the housing, designed totranslate axial movement through/within the drug delivery device,preferably from the drive member to the piston, for the purpose ofdischarging/dispensing an injectable product. Said piston rod may beflexible or not. It may be a simple rod, a lead-screw, a rack and pinionsystem, a worm gear system, or the like. The “piston rod” shall furthermean a component having a circular or non-circular cross-section. It maybe made of any suitable material known by a person skilled in the artand may be of unitary or multipart construction. In a preferredembodiment, the piston rod comprises a series of one or more sets oflongitudinally spaced ribs and/or indentations.

The term “rotating means” according to instant invention shall mean anyrotating component that transfers force and/or movement from the drivemember to the piston rod. It may be made of any suitable material knownby a person skilled in the art and may be of unitary or multipartconstruction. In a preferred embodiment the rotating means may be a gearcomponent, more preferably a spur gear. In another preferred embodimentthe rotating means may be a lever. In yet another preferred embodimentthe rotating means may be a pulley. In yet a further preferredembodiment the rotating means may be a lever assembly.

The term “gear” according to instant invention shall mean a toothedwheel used in conjunction with a rack and/or another gear, preferably arack, to transmit force and/or motion. In a preferred embodiment thegear may be a spur gear. In yet another preferred embodiment the term“gear” means a gear wheel mounted within a carrier.

The term “lever” according to instant invention shall mean any beamcomponent pivoted about a fulcrum to transmit force and/or motion. In apreferred embodiment the fulcrum point is located on the housing andload is applied through the drive member. In yet another preferredembodiment the term “lever” shall mean any beam component that movesessentially proximally with respect to the piston rod during dosesetting and that moves essentially distally with respect to the pistonrod during dose delivery.

The term “pulley” according to instant invention shall mean any wheeland/or belt component that is designed to transmit force and/or motion.In a preferred embodiment the pulley comprises a wheel and belt. In amore preferred embodiment the belt of the pulley is attached to thehousing and the drive member and the wheel of the pulley engages withthe piston rod and the belt of the pulley. In yet another preferredembodiment the wheel of the pulley is releasably engaged with the pistonrod.

The term “lever assembly” according to instant invention shall mean anycomponent consisting of a lever and a carrier designed to transmit forceand/or motion.

The term “rack” according to instant invention shall mean any componenthaving a linear array of ribs and/or indentations and/or gear-formteeth. In a preferred embodiment a rack is located in the housing and afurther rack is located in the drive member. In a further preferredembodiment one and/or both, more preferably one, of the racks located onthe housing or on the drive member is flexible and/or pivoted and/ormovable in one or more axis, more preferably one.

The term “graphical status indicator” according to instant inventionshall preferably mean any markings, symbols, numerals, etc., e.g.printed on the external surface of a component of the device, forexample the drive sleeve or an odometer or a dose dial sleeve, or thelike, preferably the drive sleeve, for indicating to the user when thedevice has been activated and/or is in operation and/or direction ofoperation and/or a dose of medicament has been delivered.

The “distal end” of the device or a component of the device shall meanthe end, which is closest to the dispensing end of the device.

The “proximal end” of the device or a component of the device shall meanthe end, which is furthest away from the dispensing end of the device.

A second aspect of instant invention provides an assembly for use in adrug delivery device comprising the drive mechanism according to instantinvention.

A third aspect of the present invention provides a drug delivery devicecomprising the drive mechanism or the assembly according to instantinvention.

A fourth aspect of the present invention provides a method of assemblinga drug delivery device comprising the step of providing a drivemechanism or an assembly according to instant invention.

A fifth aspect of instant invention is the use of a drug delivery deviceaccording to instant invention for dispensing a medicinal productpreferably dispensing a pharmaceutical formulation (e.g. solution,suspension etc.) comprising an active compound selected from the groupconsisting of insulin, growth hormone, low molecular weight heparin,their analogues and their derivatives.

BRIEF DESCRIPTION OF THE DRAWINGS

Without any limitation, the instant invention will be explained ingreater detail below in connection with a preferred embodiment and withreference to the drawings in which:

FIG. 1 shows a sectional view of a first embodiment of the drug deliverydevice in accordance with the present invention in a first, cartridgefull, position;

FIG. 1A shows a further sectional view of a first embodiment of the drugdelivery device in accordance with the present invention in a first,cartridge full, position;

FIG. 2 shows a sectional view of a first embodiment of the drug deliverydevice in accordance with the present invention in a second, first doseset, position;

FIG. 3 shows a sectional view of a first embodiment of the drug deliverydevice in accordance with the present invention in a third, final dosedispensed, position;

FIG. 4 shows a sectional view of a second embodiment of the drugdelivery device in accordance with the present invention in a first,cartridge full, position;

FIG. 5 shows a sectional view of a second embodiment of the drugdelivery device in accordance with the present invention in a second,first dose set, position;

FIG. 6 shows a sectional view of a third embodiment of the drug deliverydevice in accordance with the present invention in a first, cartridgefull, position;

FIG. 7 shows a sectional view of a third embodiment of the drug deliverydevice in accordance with the present invention in a second, first doseset, position;

FIG. 8 shows a sectional view of a fourth embodiment of the drugdelivery device in accordance with the present invention in a first,cartridge full, position;

FIG. 9 shows a further sectional view of a fourth embodiment of the drugdelivery device in accordance with the present invention in a first,cartridge full, position;

FIG. 10 shows a sectional view of a fourth embodiment of the drugdelivery device in accordance with the present invention in a second,first dose set, position.

FIG. 11 shows a sectional view of a fifth embodiment of the drugdelivery device in accordance with the present invention in a first,cartridge full, position;

FIG. 12 shows a sectional view of a fifth embodiment of the drugdelivery device in accordance with the present invention in a second,first dose set, position.

DETAILED DESCRIPTION OF THE EMBODIMENTS EXAMPLE 1

Referring first to FIGS. 1 to 3, there is shown a drug delivery devicein accordance with the present invention.

The drug delivery device (1) comprises a cartridge retaining part (2),and a main (exterior) housing part (3). The proximal end of thecartridge retaining part (2) and the distal end of the main housing (3)are secured together by any suitable means known to the person skilledin the art. In the illustrated embodiment, the cartridge retaining part(2) is secured within the distal end of the main housing part (3).

A cartridge (4) from which a number of doses of a medicinal product maybe dispensed is provided in the cartridge retaining part (2). A piston(5) is retained in the proximal end of the cartridge (4).

A removable cap (22) is releasably retained over the distal end of thecartridge retaining part (2). The removable cap (22) may be optionallyprovided with one or more window apertures through which the position ofthe piston (5) within the cartridge (4) can be viewed.

The distal end of the cartridge retaining part (2) in the illustratedembodiment, is provided with a distal threaded region (6) designed forthe attachment of a suitable needle assembly to enable medicament to bedispensed from the cartridge (4).

In the illustrated embodiment, the main housing part (3) is providedwith an internal housing (7). The internal housing (7) is securedagainst rotational and/or axial movement with respect to the mainhousing part (3). The internal housing (7) is provided with a rack (8)extending along the main axis of the internal housing (7).Alternatively, the internal housing (7) may be formed integrally withthe main housing part (3). Additionally, the internal housing (7) isprovided with a plurality of guide lugs (not shown) and pawl means (notshown). The pawl means may be an integrated part of the internal housing(7) or may be a separate component as illustrated.

A piston rod (10) extending through the main housing (3) has a first setof indentations (not shown) extending longitudinally along externalsurfaces of the piston rod (10). A second set of indentations (11)extend longitudinally along internal surfaces of the piston rod (10).The first set of indentations of the piston rod (10) extend through andare engaged with the pawl means of the internal housing (7) to preventmovement of the piston rod (10) in the proximal direction during settingof the device. A bearing surface (12) located at the distal end of thepiston rod (10) is disposed to abut the proximal face of the piston (5).In the illustrated embodiment the longitudinal spacing of the first setof indentations and the second set of indentations (11) is essentiallyequal.

A gear (13), consisting of a carrier (28) and a gear wheel (27), free torotate within the carrier (28), is located within a channel within thepiston rod (10). Pawl arms (29) located on the carrier (28) arereleasably engaged with the second set of indentations (11) of thepiston rod (10). The pawl arms (29) of the carrier (28) are designed totransmit force to the piston rod (10) in the distal direction duringdispense and to allow relative movement between the gear (13) and thepiston rod (10) in the proximal direction during setting. The teeth ofthe gear wheel (27) are permanently engaged with the teeth of the rack(8) of the internal housing (7).

A drive member (14) extends about the piston rod (10). The drive member(14) comprises a rack part (15) and an activation part (16). The rackpart (15) and the activation part (16) are secured to each other toprevent rotational and/or axial movement there between. Alternatively,the drive member (14) may be a unitary component consisting of anintegrated rack part (15) and activation part (16).

The rack part (15) is provided with a rack (17) extending along the mainaxis of the rack part (15). The teeth of the rack (17) of the rack part(15) are permanently engaged with the teeth of the gear wheel (27).

The drive member (14) has a plurality of guide slots (not shown) inwhich the guide lugs (not shown) of the internal housing (7) arelocated. These guide slots define the extent of permissible axialmovement of the drive member (14) with respect to the housing part (3).In the illustrated embodiment the guide slots also prevent rotationalmovement of the drive member (14) relative to the main housing part (3).

The activation part (16) of the drive member (14) has a plurality ofgrip surfaces (18) and a dispensing face (19).

To increase intuitiveness of the operation of the device, the mainhousing part (3) may optionally be provided with a window aperturethrough which graphical status indicators provided on the drive member(14), can be viewed.

Operation of the drug delivery device in accordance with the presentinvention will now be described.

To set a dose a user grips the grip surfaces (18) of the drive member(14). The user then pulls the drive member (14) in a proximal directionaway from the main housing part (3) thereby moving the rack part (15) ina proximal direction.

The proximal movement of the rack part (15) causes the gear wheel (27)to rotate and move proximally by virtue of the engagement of the teethof the gear wheel (27) of the gear (13) with the teeth of the rack (17)of the rack part (15) and the teeth of the rack (8) of the internalhousing (7) thus moving the gear (13) in the proximal direction.

The piston rod (10) is prevented from moving proximally by interactionof pawl means of the internal housing (7) with a first set ofindentations on the piston rod (10). As the drive member (14) travels inthe proximal direction relative to the piston rod (10), the pawl arms(29) of the carrier (28) are displaced inwardly by interaction with thesecond set of indentations (11) of the piston rod (10).

The proximal travel of the drive member (14) is limited by the guideslots of the rack part (15). At the end of the travel of the drivemember (14), the pawl arms (29) of the carrier (28) engage with the nextsequential indentation of the second set of indentations (11) of thepiston rod (10) as indicated in FIG. 2. The action of the pawl arms (29)of the carrier (28) positively engaging the second set of indentations(11) of the piston rod (10) creates an audible and tactile feedback tothe user to indicate that the dose has been set. Additionally, visualfeedback regarding dose setting may optionally be indicated by agraphical status indicator provided on the drive member (14), which canbe viewed through an optional window aperture in the main housing part(3).

When the dose has been set, the user may then dispense this dose bydepressing the dispensing face (19) of the activation part (16) of thedrive member (14). By this action the drive member (14) and the rackpart (15) are moved axially in the distal direction relative to the mainhousing part (3). As the teeth of the gear wheel (27) of the gear (13)are engaged with the teeth of the rack (17) of the rack part (15) andthe teeth of the rack (8) of the internal housing (7), the gear wheel(27) of the gear (13) is caused to rotate and move in the distaldirection thus moving the gear (13) longitudinally in the distaldirection. As the pawl arms (29) of the carrier (28) of the gear (13)are engaged with the second set of indentations (11) of the piston rod(10), the piston rod (10) is caused to move longitudinally in the distaldirection with respect to the internal housing (7).

The distal axial movement of the piston rod (10) causes the bearingsurface (12) of the piston rod (10) to bear against the piston (5) ofthe cartridge (4) causing a dose of medicament to be dispensed throughthe attached needle (not shown).

The distal travel of the drive member (14) is limited by the guide slots(not shown) of the rack part (15). Audible and tactile feedback toindicate that the dose has been dispensed is provided by the interactionof the pawl means (not shown) of the internal housing (7) with the firstset of indentations (not shown) of the piston rod (10). Additionally,visual feedback regarding dose dispensing may optionally be indicated bya graphical status indicator, provided on the drive member (14), whichcan be viewed through an optional window aperture in the main housingpart (3).

Further doses may be delivered as required up to a pre-determinedmaximum number of doses. FIG. 3 shows the drug delivery device ofinstant invention in a condition where the maximum number of doses hasbeen delivered. In this condition the proximal face (32) of the carrier(28) abuts an internal distal face (33) of the piston rod (10) toprevent further axial movement of the gear (13) and thus the drivemember (14) in proximal direction.

EXAMPLE 2

Referring to FIGS. 4 to 5, there is shown an alternative embodiment ofthe drug delivery device in accordance with the present invention.

The drug delivery device (101) comprises a cartridge retaining part(102), and a main (exterior) housing part (103). The proximal end of thecartridge retaining part (102) and the distal end of the main housing(103) are secured together by any suitable means known to the personskilled in the art. In the illustrated embodiment, the cartridgeretaining part (102) is secured within the distal end of the mainhousing part (103).

A cartridge (104) from which a number of doses of a medicinal productmay be dispensed is provided in the cartridge retaining part (102). Apiston (105) is retained in the proximal end of the cartridge (104).

The distal end of the cartridge retaining part (102) in the illustratedembodiment, is provided with a distal threaded region (106) designed forthe attachment of a suitable needle assembly (not shown) to enablemedicament to be dispensed from the cartridge (104).

In the illustrated embodiment, the main housing part (103) is providedwith an internal housing (107). The internal housing (107) is securedagainst rotational and/or axial movement with respect to the mainhousing part (103). The internal housing (107) is provided with aflexible rack (108) extending along the main axis of the internalhousing (107). Alternatively, the internal housing (107) may be formedintegrally with the main housing part (103). Additionally, the internalhousing (107) is provided with a plurality of guide slots (not shown)and pawl means (121).

A piston rod (110) extending through the main housing (103) has a set ofteeth (109) extending longitudinally along a surface of the piston rod(110). The set of teeth (109) of the piston rod (110) extend through andare engaged with the pawl means (121) of the internal housing (107) toprevent movement of the piston rod (110) in the proximal directionduring setting of the device. A bearing surface (112) located at thedistal end of the piston rod (110) is disposed to abut the proximal faceof the piston (105).

A gear (113) is located within a channel within the piston rod (110). Anaxle (128) of the gear (113) is releasably engaged with the set of teeth(109) of the piston rod (110). The set of teeth (109) are designed toallow force transmission to the piston rod (110) in the distal directionduring dispense and to allow relative movement between the gear (113)and the piston rod (110) in the proximal direction during setting. Theteeth of the gear (113) are permanently engaged with the teeth of theflexible rack (108) of the internal housing (107).

A drive member (114) extends about the piston rod (110). The drivemember (114) comprises a rack (115) and an activation part (116). Therack (115) and the activation part (116) are secured to each other toprevent rotational and/or axial movement there between. Alternatively,the drive member (114) may be a unitary component consisting of anintegrated rack (115) and activation part (116).

The teeth of the rack (115) are permanently engaged with the teeth ofthe gear (113).

The drive member (114) has a plurality of guide lugs (not shown) whichare located in the guide slots (not shown) of the internal housing(107). This defines the extent of permissible axial movement of thedrive member (114) with respect to the housing part (103). In theillustrated embodiment the guide slots also prevent rotational movementof the drive member (114) relative to the main housing part (103).

The activation part (116) of the drive member (114) has a grip surface(118) and a dispensing face (119).

To increase intuitiveness of the operation of the device, the mainhousing part (103) may optionally be provided with a window aperturethrough which optional graphical status indicators, provided on thedrive member (114), can be viewed.

Operation of the drug delivery device in accordance with the presentinvention will now be described.

To set a dose a user grips the grip surfaces (118) of the drive member(114). The user then pulls the drive member (114) in a proximaldirection away from the main housing part (103) thereby moving the rack(115) in a proximal direction.

The proximal movement of the rack (115) causes the gear (113) to rotateand move proximally by virtue of the engagement of the teeth of the gear(113) with the teeth of rack (115) and the teeth of the flexible rack(108) of the internal housing (107).

The piston rod (110) is prevented from moving proximally by interactionof pawl means (121) of the internal housing (107) with set of teeth(109) of the piston rod (110). As the drive member (114) travels in theproximal direction relative to the piston rod (110), the axle (128) ofthe gear (113) is displaced transversely by interaction with the set ofteeth (109) of the piston rod (110) thus deflecting the flexible rack(108) of the internal housing (107).

The proximal travel of the drive member (114) is limited by the guideslots (not shown) of the internal housing (107). At the end of thetravel of the drive member (114), the axle (128) of the gear (113)engages with the next sequential tooth of the set of teeth (109) of thepiston rod (110) as indicated in FIG. 5. The action of the axle (128) ofthe gear (113) positively engaging the set of teeth (109) of the pistonrod (110) under the force provided by the flexible rack (108) of theinternal housing (107) creates an audible and tactile feedback to theuser to indicate that the dose has been set. Additionally, visualfeedback regarding dose setting may optionally be indicated by agraphical status indicator, provided on the drive member (114), whichcan be viewed through an optional window aperture in the main housingpart (103).

When the dose has been set, the user may then dispense this dose bydepressing the dispensing face (119) of the activation part (116) of thedrive member (114). By this action the drive member (114) and the rack(115) are moved axially in the distal direction relative to the mainhousing part (103). As the teeth of the gear (113) are engaged with theteeth of the rack (115) and the teeth of the flexible rack (108) of theinternal housing (107) the gear (113) is rotated and moved in the distaldirection. The axle (128) of the gear (113) is engaged with the set ofteeth (109) of the piston rod (110), thereby causing the piston rod(110) to move longitudinally in the distal direction with respect to theinternal housing (107).

The distal axial movement of the piston rod (110) causes the bearingsurface (112) of the piston rod (110) to bear against the piston (105)of the cartridge (104) causing a dose of medicament to be dispensedthrough the attached needle (not shown).

The distal travel of the drive member (114) is limited by the guideslots (not shown) of the internal housing (107). Audible and tactilefeedback to indicate that the dose has been dispensed is provided by theinteraction of the pawl means (121) of the internal housing (107) withthe set of teeth (109) of the piston rod (110). Additionally, visualfeedback regarding dose dispensing may optionally be indicated by agraphical status indicator, provided on the drive member (114), whichcan be viewed through an optional window aperture in the main housingpart (103).

Further doses may be delivered as required up to a pre-determinedmaximum number of doses.

EXAMPLE 3

Referring to FIGS. 6 to 7, there is shown a further alternativeembodiment of the drug delivery device in accordance with the presentinvention.

The drug delivery device (201) comprises a cartridge retaining part(202), and a main (exterior) housing part (203). The proximal end of thecartridge retaining part (202) and the distal end of the main housing(203) are secured together by any suitable means known to the personskilled in the art. In the illustrated embodiment, the cartridgeretaining part (202) is secured within the distal end of the mainhousing part (203).

A cartridge (204) from which a number of doses of a medicinal productmay be dispensed is provided in the cartridge retaining part (202). Apiston (205) is retained in the proximal end of the cartridge (204).

The distal end of the cartridge retaining part (202) in the illustratedembodiment, is provided with a distal threaded region (206) designed forthe attachment of a suitable needle assembly to enable medicament to bedispensed from the cartridge (204).

In the illustrated embodiment, the main housing part (203) is providedwith an internal housing (207). The internal housing (207) is securedagainst rotational and/or axial movement with respect to the mainhousing part (203). The internal housing (207) is provided with a fixingpoint (208) for attaching a pulley (240). Alternatively, the internalhousing (207) may be formed integrally with the main housing part (203).Additionally, the internal housing (207) is provided with a guide slot(not shown) and pawl means (not shown).

A piston rod (210) extending through the main housing (203) has a firstset of teeth (209) and a second set of teeth (211) extendinglongitudinally along surfaces of the piston rod (210). The second set ofteeth (211) of the piston rod (210) extends through and is engaged withthe pawl means (not shown) of the internal housing (207) to preventmovement of the piston rod (210) in the proximal direction duringsetting of the device. A bearing surface (212) located at the distal endof the piston rod (210) is disposed to abut the proximal face of thepiston (205).

A pulley (240), comprising a belt (241) and a wheel (242) is locatedwithin a channel within the piston rod (210). An axle (228) of the wheel(242) is releasably engaged with the first set of teeth (209) of thepiston rod (210). The first set of teeth (209) are designed to allowforce transmission to the piston rod (210) in the distal directionduring dispense and to allow relative movement between the pulley (240)and the piston rod (210) in the proximal direction during setting. Theteeth of the wheel (242) are permanently engaged with the teeth of thebelt (241) of pulley (240).

A drive member (214) extends about the piston rod (210). The drivemember (214) comprises a fixing point (215) and an activation part(216). The fixing point (215) and the activation part (216) are securedto each other to prevent rotational and/or axial movement there between.Alternatively, the drive member (214) may be a unitary componentconsisting of an integrated fixing point (215) and activation part(216).

The belt (241) of the pulley (240) is attached to the drive member (214)at the fixing point (215).

The drive member (214) has a guide lug (not shown) which is located inthe guide slot (not shown) of the internal housing (207). This definesthe extent of permissible axial movement of the drive member (214) withrespect to the housing part (203). In the illustrated embodiment theguide slot also prevents rotational movement of the drive member (214)relative to the main housing part (203).

The activation part (216) of the drive member (214) has a grip surface(218) and a dispensing face (219).

To increase intuitiveness of the operation of the device, the mainhousing part (203) may be provided with an optional window aperturethrough which optional graphical status indicators, provided on thedrive member (214), can be viewed.

Operation of the drug delivery device in accordance with the presentinvention will now be described.

To set a dose a user grips the grip surfaces (218) of the drive member(214). The user then pulls the drive member (214) in a proximaldirection away from the main housing part (203) thereby moving thefixing point (215) in a proximal direction.

The proximal movement of the drive member (214) causes the wheel (242)of the pulley (240) to rotate and move proximally by virtue of theattachment of the belt (241) of the pulley (240) to both the fixingpoint (215) of the drive member (214) and the fixing point (208) of theinternal housing (207).

The piston rod (210) is prevented from moving proximally by theinteraction of pawl means (not shown) of the internal housing (207) withthe second set of teeth (211) of the piston rod (210). As the drivemember (214) travels in the proximal direction relative to the pistonrod (210), the axle (228) of the wheel (242) is displaced transverselyby interaction with the first set of teeth (209) of the piston rod (210)thus deflecting the belt (241) of the pulley (240).

The proximal travel of the drive member (214) is limited by the guideslot (not shown) of the internal housing (207). At the end of the travelof the drive member (214), the axle (228) of the wheel (242) engageswith the next sequential tooth of the first set of teeth (209) of thepiston rod (210) as indicated in FIG. 7. The action of the axle (228) ofthe wheel (242) positively engaging the first set of teeth (209) of thepiston rod (210) under the force provided by the belt (241) of thepulley (240) creates an audible and tactile feedback to the user toindicate that the dose has been set. Additionally, visual feedbackregarding dose setting may optionally be indicated by a graphical statusindicator, provided on the drive member (214), which can be viewedthrough an optional window aperture in the main housing part (203).

When the dose has been set, the user may then dispense this dose bydepressing the dispensing face (219) of the activation part (216) of thedrive member (214). By this action the drive member (214) and the fixingpoint (215) are moved axially in the distal direction relative to themain housing part (203). As the belt (241) of the pulley (240) isattached to the fixing point (215) of the drive member (214) and thebelt (241) of the pulley (240) is also attached to the fixing point(208) of the internal housing (207) the wheel (242) of the pulley (240)is rotated and moved in the distal direction by the engagement of theteeth of the belt (241) with the teeth of the wheel (242). The axle(228) of the wheel (242) of the pulley (240) is engaged with the firstset of teeth (209) of the piston rod (210), thereby causing the pistonrod (210) to move axially in the distal direction with respect to theinternal housing (207).

The distal axial movement of the piston rod (210) causes the bearingsurface (212) of the piston rod (210) to bear against the piston (205)of the cartridge (204) causing a dose of medicament to be dispensedthrough the attached needle (not shown).

The distal travel of the drive member (214) is limited by the guide slot(not shown) of the internal housing (207). Audible and tactile feedbackto indicate that the dose has been dispensed is provided by theinteraction of the pawl means (not shown) of the internal housing (207)with the second set of teeth (211) of the piston rod (210).Additionally, visual feedback regarding dose dispensing may optionallybe indicated by a graphical status indicator, provided on the drivemember (214), which can be viewed through an optional window aperture inthe main housing part (203).

Further doses may be delivered as required up to a pre-determinedmaximum number of doses.

EXAMPLE 4

Referring to FIGS. 8 to 10, there is shown a further alternativeembodiment of the drug delivery device in accordance with the presentinvention.

The drug delivery device (301) comprises a cartridge retaining part(302), and a main (exterior) housing part (303). The proximal end of thecartridge retaining part (302) and the distal end of the main housing(303) are secured together by any suitable means known to the personskilled in the art. In the illustrated embodiment, the cartridgeretaining part (302) is secured within the distal end of the mainhousing part (303).

A cartridge (304) from which a number of doses of a medicinal productmay be dispensed is provided in the cartridge retaining part (302). Apiston (305) is retained in the proximal end of the cartridge (304).

The distal end of the cartridge retaining part (302) in the illustratedembodiment, is provided with a distal threaded region (306) designed forthe attachment of a suitable needle assembly (not shown) to enablemedicament to be dispensed from the cartridge (304).

In the illustrated embodiment, the main housing part (303) is providedwith an internal housing (307). The internal housing (307) is securedagainst rotational and/or axial movement with respect to the mainhousing part (303). The internal housing (307) is provided with afulcrum point (308) for attaching a lever (340). Alternatively, theinternal housing (307) may be formed integrally with the main housingpart (303).

Additionally, the internal housing (307) is provided with a guide slots(not shown) and pawl means (345).

A piston rod (310) extending through the main housing (303) has a firstset of indentations (309 and 309′) and a second set of indentations (311and 311′) extending longitudinally along surfaces of the piston rod(310). The second net of indentations (311 and 311′) of the piston rod(310) extends through and is engaged with the pawl means (345) of theinternal housing (307) to prevent movement of the piston rod (310) inthe proximal direction during setting of the device. A bearing surface(312) located at the distal end of the piston rod (310) is disposed toabut the proximal face of the piston (305).

A lever (340), comprising a plurality of lugs (341) and a first pivot(342) and a second pivot (343), is located within a channel within thepiston rod (310). The lugs (341) of the lever (340) are releasablyengaged with the first set of indentations (309 and 309′) of the pistonrod (310). The first set of indentations (309 and 309′) are designed toallow force transmission to the piston rod (310) in the distal directionduring dispense and to allow relative movement between the lever (340)and the piston rod (310) in the proximal direction during setting. Thefirst pivot (342) of the lever (340) is attached to the fulcrum (308) ofthe internal housing (307) for pivotable movement there between.

A drive member (314) extends about the piston rod (310). The drivemember (314) comprises a slot (315) and an activation part (316). Theslot (315) and the activation part (316) are secured to each other toprevent rotational and/or axial movement there between. Alternatively,the drive member (314) may be a unitary component consisting of anintegrated slot (315) and activation part (316).

The second pivot (343) of the lever (340) is located within the slot(315) of the drive member (314). The slot (315) of the drive member(314) is designed to allow transverse movement, but not longitudinalmovement, of the second pivot (343) of the lever (340) relative to thedrive member (314).

The drive member (314) has guide lugs (346) which are located in theguide slots (not shown) of the internal housing (307). This defines theextent of permissible axial movement of the drive member (314) withrespect to the housing part (303). In the illustrated embodiment theguide slots also prevent rotational movement of the drive member (314)relative to the main housing part (303).

The activation part (316) of the drive member (314) has a grip surface(318) and a dispensing face (319).

To increase intuitiveness of the operation of the device, the mainhousing part (303) may be provided with an optional window aperturethrough which optional graphical status indicators, provided on thedrive member (314), can be viewed.

Operation of the drug delivery device in accordance with the presentinvention will now be described.

To set a dose a user grips the grip surfaces (318) of the drive member(314). The user then pulls the drive member (314) in a proximaldirection away from the main housing part (303) thereby moving thefixing point (315) in a proximal direction.

The proximal movement of the drive member (314) causes the lever (340)to rotate about the fulcrum (308) of the internal housing (307) in aproximal direction by virtue of the location of the second pivot (343)of the lever (340) within the slot (315) of the drive member (314).

The piston rod (310) is prevented from moving proximally by interactionof pawl means (345) of the internal housing (307) with the second set ofindentations (311 and 311′) of the piston rod (310). As the drive member(314) travels in the proximal direction relative to the piston rod(310), the lugs (341) of the lever (340) are displaced transversely byinteraction with the first set of indentations (309 and 309′) of thepiston rod (310).

The proximal travel of the drive member (314) is limited by the guideslots (not shown) of the internal housing (307). At the end of thetravel of the drive member (314), the lugs (341) of the lever (340)engage with the next sequential indentation of the first set ofindentations (309 and 309′) of the piston rod (310) as indicated in FIG.10. The action of the lugs (341) of the lever (340) positively engagingthe first set of indentations (309 and 309′) of the piston rod (310)under a force provided by the transverse deflection of the lever (340)creates an audible and tactile feedback to the user to indicate that thedose has been set. Additionally, visual feedback regarding dose settingmay optionally be indicated by a graphical status indicator, provided onthe drive member (314), which can be viewed through an optional windowaperture in the main housing part (303).

When the dose has been set, the user may then dispense this dose bydepressing the dispensing face (319) of the activation part (316) of thedrive member (314). By this action the drive member (314) and the slot(315) are moved axially in the distal direction relative to the mainhousing part (303). As the second pivot (343) of the lever (340) islocated within the slot (315) of the drive member (314), the lever (340)is rotated about the fulcrum (308) of the internal housing (307) in thedistal direction. The lugs (341) of the lever (340) are engaged with thefirst set of indentations (309 and 309′) of the piston rod (310),thereby causing the piston rod (310) to move axially in the distaldirection with respect to the internal housing (307).

The distal axial movement of the piston rod (310) causes the bearingsurface (312) of the piston rod (310) to bear against the piston (305)of the cartridge (304) causing a dose of medicament to be dispensedthrough the attached needle (not shown).

The distal travel of the drive member (314) is limited by the guideslots (not shown) of the internal housing (307). Audible and tactilefeedback to indicate that the dose has been dispensed is provided by theinteraction of the pawl means (345) of the internal housing (307) withthe second set of indentations (311 and 311′) of the piston rod (310).Additionally, visual feedback regarding dose dispensing may optionallybe indicated by a graphical status indicator, provided on the drivemember (314), which can be viewed through an optional window aperture inthe main housing part (303).

Further doses may be delivered as required up to a pre-determinedmaximum number of doses.

EXAMPLE 5

Referring to FIGS. 11 to 12, there is shown a further alternativeembodiment of the drug delivery device in accordance with the presentinvention.

The drug delivery device (401) comprises a cartridge retaining part(402), and a main (exterior) housing part (403). The proximal end of thecartridge retaining part (402) and the distal end of the main housing(403) are secured together by any suitable means known to the personskilled in the art. In the illustrated embodiment, the cartridgeretaining part (402) is secured within the distal end of the mainhousing part (403).

A cartridge (404) from which a number of doses of a medicinal productmay be dispensed is provided in the cartridge retaining part (402). Apiston (405) is retained in the proximal end of the cartridge (404).

A removable cap (422) is releasably retained over the distal end of thecartridge retaining part (402). The removable cap (422) is optionallyprovided with one or more window apertures through which the position ofthe piston (405) within the cartridge (404) can be viewed.

The distal end of the cartridge retaining part (402) in the illustratedembodiment, is provided with a distal threaded region (406) designed forthe attachment of a suitable needle assembly (not shown) to enablemedicament to be dispensed from the cartridge (404).

In the illustrated embodiment, the main housing part (403) is providedwith an internal housing (407). The internal housing (407) is securedagainst rotational and/or axial movement with respect to the mainhousing part (403). The internal housing (407) is provided with afulcrum (408). Alternatively, the internal housing (407) may be formedintegrally with the main housing part (403). Additionally, the internalhousing (407) is provided with a plurality of guide lugs (not shown) andpawl means (not shown). The pawl means may be an integrated part of theinternal housing (407) or may be a separate component as illustrated.

A piston rod (410) extending through the main housing (403) has a firstset of indentations (not shown) extending longitudinally along externalsurfaces of the piston rod (410). A second set of indentations (411)extend longitudinally along internal surfaces of the piston rod (410).The first set of indentations of the piston rod (410) extend through andare engaged with the pawl means of the internal housing (407) to preventmovement of the piston rod (410) in the proximal direction duringsetting of the device. A bearing surface (412) located at the distal endof the piston rod (410) is disposed to abut the proximal face of thepiston (405). In the illustrated embodiment the longitudinal spacing ofthe first set of indentations and the second set of indentations (411)is essentially equal.

A lever assembly (413), consisting of a carrier (428) and a lever (427),free to rotate within the carrier (428), is located within a channelwithin the piston rod (410). The lever (427) is provided with a firstpivot (442) and a second pivot (443). Pawl arms (429) located on thecarrier (428) are releasably engaged with the second set of indentations(411) of the piston rod (410). The pawl arms (429) of the carrier (428)are designed to transmit force to the piston rod (410) in the distaldirection during dispense and to allow relative movement between thelever assembly (413) and the piston rod (410) in the proximal directionduring setting. The first pivot (442) of the lever (427) is attached tothe fulcrum (408) of the internal housing (407) for pivotable movementthere between.

A drive member (414) extends about the piston rod (410). The drivemember (414) comprises a slotted part (415) and an activation part(416). The slotted part (415) and the activation part (416) are securedto each other to prevent rotational and/or axial movement there between.Alternatively, the drive member (414) may be a unitary componentconsisting of an integrated slotted part (415) and activation part(416).

The slotted part (415) is provided with a slot (417) that is essentiallyperpendicular to the main axis of the drive member (414). The secondpivot (443) of the lever (427) is located within the slot (417) of theinternal housing (407). The slot (415) of the drive member (414) isdesigned to allow transverse movement, but not longitudinal movement, ofthe second pivot (443) of the lever (427) relative to the drive member(414).

The drive member (414) has a plurality of guide slots (not shown) inwhich the guide lugs (not shown) of the internal housing (407) arelocated. These guide slots define the extent of permissible axialmovement of the drive member (414) with respect to the housing part(403). In the illustrated embodiment the guide slots also preventrotational movement of the drive member (414) relative to the mainhousing part (403).

The activation part (416) of the drive member (414) has a plurality ofgrip surfaces (418) and a dispensing face (419).

To increase intuitiveness of the operation of the device, the mainhousing part (403) may be provided with an optional window aperturethrough which optional graphical status indicators, provided on thedrive member (414), can be viewed.

Operation of the drug delivery device in accordance with the presentinvention will now be described.

To set a dose a user grips the grip surfaces (418) of the drive member(414). The user then pulls the drive member (414) in a proximaldirection away from the main housing part (403) thereby moving theslotted part (415) in a proximal direction.

The proximal movement of the drive member (414) causes the lever (427)to rotate about the fulcrum (408) of the internal housing (407) in aproximal direction by virtue of the location of the second pivot (443)of the lever (427) within the slot (417) of the drive member (414).

The piston rod (410) is prevented from moving proximally by interactionof pawl means (not shown) of the internal housing (407) with the firstset of indentations (not shown) of the piston rod (410). As the drivemember (414) travels in the proximal direction relative to the pistonrod (410), the pawl arms (429) of the carrier (428) are displacedinwardly by interaction with the second set of indentations (411) of thepiston rod (410).

The proximal travel of the drive member (414) is limited by the guideslots (not shown) of the slotted part (415). At the end of the travel ofthe drive member (414), the pawl arms (429) of the carrier (428) engagewith the next sequential indentation of the second set of indentations(411) of the piston rod (410) as indicated in FIG. 12. The action of thepawl arms (429) of the carrier (428) positively engaging the second setof indentations (411) of the piston rod (410) creates an audible andtactile feedback to the user to indicate that the dose has been set.Additionally, visual feedback regarding dose setting may optionally beindicated by a graphical status indicator, provided on the drive member(414), which can be viewed through an optional window aperture in themain housing part (403).

When the dose has been set, the user may then dispense this dose bydepressing the dispensing face (419) of the activation part (416) of thedrive member (414). By this action the drive member (414) and theslotted part (415) are moved axially in the distal direction relative tothe main housing part (403). As the second pivot (443) of the lever(427) is located within the slot (417) of the drive member (414), thelever (427) is rotated about the fulcrum (408) of the internal housing(407) in the distal direction. As the pawl arms (429) of the carrier(428) of the lever assembly (413) are engaged with the second set ofindentations (411) of the piston rod (410), the piston rod (410) iscaused to move longitudinally in the distal direction with respect tothe internal housing (407).

The distal axial movement of the piston rod (410) causes the bearingsurface (412) of the piston rod (410) to bear against the piston (405)of the cartridge (404) causing a dose of medicament to be dispensedthrough the attached needle.

The distal travel of the drive member (414) is limited by the guideslots (not shown) of the slotted part (415). Audible and tactilefeedback to indicate that the dose has been dispensed is provided by theinteraction of the pawl means (not shown) of the internal housing (407)with the first set of indentations (not shown) of the piston rod (410).Additionally, visual feedback regarding dose dispensing may optionallybe indicated by a graphical status indicator, provided on the drivemember (414), which can be viewed through an optional window aperture inthe main housing part (403).

Further doses may be delivered as required up to a pre-determinedmaximum number of doses.

1. A drive mechanism for use with a delivery device, the drive mechanismcomprising: a rack that is moveable in a proximal direction and in adistal direction; a piston rod releasably engaged with said moveablerack, said piston rod comprising a first plurality of indentations alongat least a portion of said piston rod; and a rotating component thattransfers movement between said movable rack and said piston rod, saidrotating component releasably engaged with said first plurality ofindentations of said piston rod.
 2. The drive mechanism of claim 1wherein when said drive mechanism is used to set a dose of a medicamentcontained within a drug delivery device, said rack is moved proximallywith respect to said piston rod.
 3. The drive mechanism of claim 2wherein when said drive mechanism is used to set of dose of a medicamentcontained within a drug delivery device, said rotating component movesproximally with respect to said piston rod.
 4. The drive mechanism ofclaim 3 further comprising a drive member operatively coupled to saidmovable rack such that when said drive member is moved in the proximaldirection with respect to said piston rod, said moveable rack is alsomoved in proximally with respect to said piston rod.
 5. The drivemechanism of claim 1 wherein said piston rod further comprises a secondplurality of indentations, said second plurality of indentationsresiding along an external surface of said piston rod.
 6. The drivemechanism of claim 5 wherein said second plurality of indentations areconfigured to releasably engage a housing of a drug delivery device soas to prevent said piston rod from moving in a proximal direction. 7.The drive mechanism of claim 1 wherein said drive mechanism isconfigured to be coupled to a cartridge retaining part.
 8. The drivemechanism of claim 7 wherein said drive mechanism is configured to bereleasably coupled to the cartridge retaining part.
 9. The drivemechanism of claim 1 wherein said drive mechanism can be used toadminister one or more pre-set doses of a medicament contained within adrug delivery device.
 10. The drive mechanism of claim 1 wherein saidrotating component comprises a gear, said gear comprising a carrier anda gear wheel.
 11. The drive mechanism of claim 10 wherein said carrieris operatively coupled to said piston rod.
 12. A piston rod for use witha drug delivery device, comprising a main piston rod shaft extendingfrom a distal end to a proximal end, said main piston rod shaftcomprising a channel; a bearing surface provided at said distal end ofsaid main piston rod shaft, said bearing surface configured to abut aproximal face of a piston of a cartridge contained within a drugdelivery device; first indentations extending along an external surfaceof said piston rod; and second indentations extending along an internalsurface of said channel of said piston rod.
 13. The piston rod of claim12 wherein said piston rod is used for an administration of at least onepre-set dose of a medicament contained within a drug delivery device.14. The piston rod of claim 12 wherein a longitudinal spacing of saidfirst set of indentations and a longitudinal spacing of said second setof indentations are essentially equal.
 15. The piston rod of claim 12wherein said piston rod is configured to be releasably engaged to arotating component that transfers movement between a movable rack andsaid piston rod, said rotating component releasably engaged with saidchannel of said piston rod.
 16. The piston rod of claim 15 furthercomprising an internal distal face, said internal distal face preventingproximal movement of said rotating member when said rotating member hasmoved in the proximal direction so as to abut said internal distal face.17. The piston rod of claim 12 wherein said first indentations extendingalong said outer surface of said piston rod are configured to interactwith a housing of a drug delivery device so as to prevent said pistonrod from moving proximally.
 18. A method of setting a dose with a drivemechanism, the method comprising the steps of: arranging a drive memberwithin a housing so that said drive member is movable in a proximal anda distal direction; configuring one set of indentations along aninternal surface of a piston rod; releasably engaging a rotatingcomponent with said one set of indentations of said piston rod; movingsaid drive member proximally with respect to the said housing, andmoving said rotating component proximally with respect to the saidpiston rod.
 19. The method of claim 18 further comprising the step ofreleasably engaging a housing with a second set of indentations of saidpiston rod to thereby prevent said piston rod from moving in a proximaldirection.
 20. The method of claim 18 further comprising the step ofmoving said drive member in a distal direction, and moving said rotatingcomponent in a distal direction, thereby displacing the said piston rodtowards a distal end of the drive mechanism.